ABSTRACT
The migration of diethylhexyl phthalate (DEHP) from PVC bags into LVPS (0.9% NaCl) and LVPS with cyclosporine at concentrations of 2.5 and 0.5mg/ml was studied. PVC bags were placed in contact with these solutions and stored at 25+/-1 degrees C. They were taken for analysis each 30 min during 6 h and after this period at each 1 h until 12 h of contact. Water was used as reference, and exposed and analyzed under the same conditions. After contact, the solutions were submitted to extraction with hexane and analyzed by GC-FID. The results showed that DEHP did not migrate into water and LVPS during all the time. Also, no measurable amount of DEHP was detected during the first 3 h of contact between the PVC bag and the diluted cyclosporine solution. However, the amount of released DEHP reached a detectable level after 4 h of contact, increased until 6 h, stabilized, and increased again after 9-10 h. The 12 h of contact showed the highest DEHP levels for both cyclosporine concentrations. The DEHP migrated was 0.02-0.08% of that present in the bag.
Subject(s)
Cyclosporine/chemistry , Diethylhexyl Phthalate/analysis , Drug Packaging , Immunosuppressive Agents/chemistry , Polyvinyl Chloride/analysis , Chromatography, Gas , Chromatography, High Pressure Liquid , Cyclosporine/administration & dosage , Immunosuppressive Agents/administration & dosage , Infusions, Intravenous , Kinetics , Pharmaceutical SolutionsABSTRACT
Soluções parenterais de grandes volumes (SPGV) têm sido amplamente utilizadas como veículos para a administração de fármacos por via intravenosa e as bolsas flexíveis de policloreto de vinila (PVC) são, atualmente, os recipientes plásticos mais usados no acondicionamento das SPGV, apresentando vantagens relacionadas à sua colapsação e à redução de contaminações e de embolias gasosas. Este artigo apresenta uma revisão sobre aspectos relevantes das embalagens de PVC contendo o plastificante ftalato de di-(2-etilexila) (DEHP), que são usadas para acondicionamento de SPGV. São abordadas as interações entre fármacos e a embalagem, com ênfase no fenômeno da migração do DEHP presente em bolsas plásticas de PVC para SPGV contendo ciclosporina, um fármaco com atividade imunossupressora, e os aspectos toxicológicos inerentes
Subject(s)
Humans , Cyclosporine/pharmacology , Cyclosporine/toxicity , Drug Packaging , Drug Stability , Infusions, Parenteral , Polyvinyl Chloride , Plastics/adverse effects , Plastics/toxicityABSTRACT
In this report an analytical method to determine furosemide by using diffuse reflectance spectroscopy is presented. This study shows that this technique can give quantitative results using spot test analysis, particularly in the case of pharmaceuticals containing furosemide. The color spot test could be obtained by reaction between furosemide with p-dimethylaminocinnamaldehyde, in acid medium. This reaction produced a stable complex on filter paper after heating to 80 degrees C for 5min. All reflectance measurements were carried out at 585nm and the linear range was from 7.56x10(-3) to 6.05x10(-2)moll(-1), with a correlation coefficient of 0.999. The limit of detection was estimated to be 2.49x10(-3)moll(-1) (R.S.D.=1.7%) and the effect of common excipients on the reflectance measurements was evaluated. The method was applied to determine furosemide in commercial brands of pharmaceuticals. The results obtained by the proposed method were favorably compared with those of the official method, showing for the first time ever that quantitative spot test analysis by diffuse reflectance could be successfully used to determine furosemide in tablets.
ABSTRACT
An original, simple, specific, and rapid high-performance liquid chromatography assay for the determination of clofazimine in human plasma is presented. The procedure consists of extracting the drug and the internal standard (medazepam) from 0.5 mL plasma with dichloromethane/diisopropyl ether (1:1, v/v) at pH 3.0, after precipitating the proteins with methanol. The drugs were then quantitated on a reversed-phase C8 using a mobile phase consisting of a mixture of methanol/0.25 N sodium acetate buffer at pH 3.0 (74:26, v/v). The flow-rate and wavelength were set at 1 mL/min and 286 nm, respectively. The precision, linearity, and limit of quantitation of the method were within acceptable limits. The method was considered adequate and could be applied in studies involving blood level monitoring and pharmacokinetics in leprosy patients.
Subject(s)
Chromatography, High Pressure Liquid/methods , Clofazimine/pharmacokinetics , Drug Monitoring/methods , Leprostatic Agents/pharmacokinetics , Leprosy/metabolism , Clofazimine/therapeutic use , Female , Humans , Leprostatic Agents/therapeutic use , Leprosy/drug therapy , Male , Reproducibility of Results , Sensitivity and SpecificityABSTRACT
An original, simple, specific, and rapid high-performance liquid chromatography assay for the determination of clofazimine in human plasma is presented. The procedure consists of extracting the drug and the internal standard (medazepam) from 0.5 mL plasma with dichloromethane/diisopropyl ether (1:1, v/v) at pH 3.0, after precipitating the proteins with methanol. The drugs were then quantitated on a reversed-phase C8 using a mobile phase consisting of a mixture of methanol/0.25 N sodium acetate buffer at pH 3.0 (74:26, v/v). The flow-rate and wavelength were set at 1 mL/min and 286 nm, respectively. The precision, linearity, and limit of quantitation of the method were within acceptable limits. The method was considered adequate and could be applied in studies involving blood level monitoring and pharmacokinetics in leprosy patients.